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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) Southwest Oncology Group Eastern Cooperative Oncology Group North Central Cancer Treatment Group European Organization for Research and Treatment of Cancer National Cancer Institute of Canada |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002968 |
RATIONALE: Monoclonal antibodies such as edrecolomab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether surgery to remove colon cancer is more effect with or without monoclonal antibody therapy.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without monoclonal antibody therapy in treating patients who have stage II colon cancer.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: edrecolomab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Phase III Randomized Study of Adjuvant Immunotherapy With Monoclonal Antibody 17-1A Versus No Adjuvant Therapy Following Resection for State II (Modified Astler-Coller B2) Adenocarcinoma of the Colon |
Estimated Enrollment: | 2100 |
Study Start Date: | May 1997 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to degree of differentiation (well vs moderately well vs poor), vascular or lymphatic invasion (no vs yes), and preoperative serum CEA (less than 5.0 ng/mL vs at least 5.0 ng/mL vs unknown). Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 2,100 patients will be accrued for this study within 4.7 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven adenocarcinoma of the colon (Stage II pT3, N0 or pT4b, N0, excluding pT4a, N0)
Complete en bloc resection of all primary tumors (not performed or assisted by laparoscopic methods)
PATIENT CHARACTERISTICS:
Age:
Performance Status:
Life Expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Canada | |
Lions Gate Hospital | |
North Vancouver, Canada, V7L 2P9 | |
Canada, Alberta | |
Cross Cancer Institute | |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Tom Baker Cancer Center - Calgary | |
Calgary, Alberta, Canada, T2N 4N2 | |
Canada, British Columbia | |
British Columbia Cancer Agency - Centre for the Southern Interior | |
Kelowna, British Columbia, Canada, V1Y 5L3 | |
British Columbia Cancer Agency - Fraser Valley Cancer Centre | |
Surrey, British Columbia, Canada, V3V 1Z2 | |
Nanaimo Cancer Clinic | |
Nanaimo, British Columbia, Canada, V9S 2B7 | |
Canada, Manitoba | |
CancerCare Manitoba | |
Winnipeg, Manitoba, Canada, R3E 0V9 | |
Canada, New Brunswick | |
Doctor Leon Richard Oncology Centre | |
Moncton, New Brunswick, Canada, E1C 8X3 | |
Moncton Hospital | |
Moncton, New Brunswick, Canada, E1C 6ZB | |
Canada, Ontario | |
Algoma District Medical Group | |
Sault Sainte Marie, Ontario, Canada, P6B 1Y5 | |
Cancer Care Ontario-Hamilton Regional Cancer Centre | |
Hamilton, Ontario, Canada, L8V 5C2 | |
Cancer Care Ontario-London Regional Cancer Centre | |
London, Ontario, Canada, N6A 4L6 | |
Mount Sinai Hospital - Toronto | |
Toronto, Ontario, Canada, M5G 1X5 | |
Hotel Dieu Health Sciences Hospital - Niagara | |
St. Catharines, Ontario, Canada, L2R 5K3 | |
Kingston Regional Cancer Centre | |
Kingston, Ontario, Canada, K7L 5P9 | |
Credit Valley Hospital | |
Mississauga, Ontario, Canada, L5M 2N1 | |
Northeastern Ontario Regional Cancer Centre, Sudbury | |
Sudbury, Ontario, Canada, P3E 5J1 | |
Northwestern Ontario Regional Cancer Centre, Thunder Bay | |
Thunder Bay, Ontario, Canada, P7A 7T1 | |
Ottawa Regional Cancer Centre | |
Ottawa, Ontario, Canada, K1H 1C4 | |
Peterborough Oncology Clinic | |
Peterborough, Ontario, Canada, K9H 7B6 | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
Scarborough Hospital - General Site | |
Scarborough, Ontario, Canada, M1P 2V5 | |
Toronto Sunnybrook Regional Cancer Centre | |
Toronto, Ontario, Canada, M4N 3M5 | |
Canada, Prince Edward Island | |
Queen Elizabeth Hospital, PEI | |
Charlottetown, Prince Edward Island, Canada, C1A 8T5 | |
Canada, Quebec | |
McGill University | |
Montreal, Quebec, Canada, H2W 1S6 | |
CHUM Hopital Saint-Luc | |
Montreal, Quebec, Canada, H2X 3J4 | |
Complexe Hospitalier de la Sagamie | |
Chicoutimi, Quebec, Canada, G7H 5H6 | |
Hopital Du Sacre-Coeur de Montreal | |
Montreal, Quebec, Canada, H4J 1C5 | |
L'Hopital Laval | |
Ste-Foy, Quebec, Canada, G1V 4G5 | |
L'Hotel Dieu de Levis | |
Levis, Quebec, Canada, G6V 3Z1 | |
Maisonneuve-Rosemont Hospital | |
Montreal, Quebec, Canada, H1T 2M4 | |
Centre Hospitalier Universitaire de Quebec | |
Quebec City, Quebec, Canada, G1R 2J6 |
Study Chair: | Thomas A. Colacchio, MD | Norris Cotton Cancer Center |
Study Chair: | S. G. Eckhardt, MD | University of Colorado at Denver and Health Sciences Center |
Study Chair: | Al B. Benson, MD, FACP | Robert H. Lurie Cancer Center |
Study Chair: | Richard M. Goldberg, MD | Mayo Clinic |
Study Chair: | Philippe Rougier, MD | Hopital Ambroise Pare |
Study Chair: | Anthony L.A. Fields, MD, FRCPC | Cross Cancer Institute at University of Alberta |
Study ID Numbers: | CDR0000065473, CLB-9581, CAN-NCIC-CO14, E-C9581, EORTC-40991, NCCTG-C9581, SWOG-C9581 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002968 |
Health Authority: | United States: Federal Government |
stage II colon cancer adenocarcinoma of the colon |
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms Antibodies, Monoclonal |
Monoclonal antibody 17-1A Antibodies Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Colorectal Neoplasms Immunoglobulins |
Neoplasms Neoplasms by Site Immunologic Factors Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Pharmacologic Actions |